An inspector from an accreditation organization performs a CLIA inspection at a clinical laboratory once every two years at a minimum. If the inspection exposes deficiencies in the lab meeting the regulatory requirements, the lab may take a lot of time and effort to make corrections. Prepare by knowing the common deficiencies found in CLIA inspections.
Testing Personnel Competency
Laboratories must assess personnel’s competency. This requirement includes testing consultant competency, if applicable. Lab staff must write and follow policies and procedures for assessment.
Competency assessment is performed by directly observing the personnel’s actions, monitoring reports, reviewing test results, assessing test performance, and evaluating problem-solving skills. The lab must assess the personnel’s competency for each test the lab director asks them to perform. Depending on the lab’s complexity, the Technical Consultant or Technical Supervisor must perform and document the assessments.
Another common deficiency found in CLIA inspections is improper reagent storage. Reagents must meet quality standards and cannot exceed the expiration date or have deteriorated. Labs must store reagents based on the manufacturers’ instructions.
Monitor and document reagent storage conditions. Include relevant information like water quality, temperature, humidity, and protection from electrical current fluctuations and interruptions.
Reagents must also be labeled with pertinent information required for proper use. For a thorough understanding of how well your lab meets the standard for reagent storage and more, consider hiring an inspection preparation consultant to help you pass the inspection.
General Laboratory Systems Quality Assessment
Quality assessment (QA) evaluates results obtained in the lab using known standards. Through QA, a lab can validate quality control and quality assurance programs. QA results indicate the effectiveness of all or part of the lab’s quality management system.
During QA, an internal staff member or external agency examines the lab’s performance by collecting and analyzing data. Lab personnel must make a report, take corrective action, and document quality assurance activities when it does not meet standards.
Assuring your lab meets the standards for assessing personnel competency, storing reagents, and QA is only part of securing accreditation. Laboratories should remain prepared for inspection, as an inspector can visit unexpectedly at any time.